510(k) Report

510(k) · Cleared

Recalled · 2008

CT HDR Tandem/Ring Applicator with Rectal Retractor

K030110510(k) TraditionalCleared Apr 3, 200380-day reviewClass II21 CFR 892.5700Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mick Radio-Nuclear Instruments, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Apr 3, 2003 as substantially equivalent to K011657 (Mick Radio-Nuclear Instruments, Inc., 2001) after an 80-day review. Its family tree reaches back 3 generations to 1986. 9 later devices descend from it. It has been recalled once.

Decided
Apr 3, 2003
Review
80 days
Class
Class II
Product code
JAQ
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K864210 (1986). 4 ancestors in all. 9 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor2006: 2 descendants cleared2012: 1 descendant cleared2015: 2 descendants cleared2020: 1 descendant cleared2008: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 1986K953946 · Microselectron-HDR Version 2 · Nucletron-Oldelft Corp. · 1996K011657 · HDR Tandem/Ring Applicator with Rectal Retractor · Mick Radio-Nuclear Instruments, Inc. · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K011657 · HDR Tandem/Ring Applicator with Rectal Retractor · Mick Radio-Nuclear Instruments, Inc. · 2001 · recalledK953946 · Microselectron-HDR Version 2 · Nucletron-Oldelft Corp. · 1996K864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 19860
  1. Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
  2. 2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
  3. 1 generation backK011657 HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2001 · Recalled
  4. This deviceK030110 CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2003
  5. Descendant · cites it directly · 2 of its ownK150839 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring…Varian Medical Systems, Inc. · 2015
  6. Descendant · cites it directly · 2 of its ownK122840 CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc. · 2012
  7. Descendant · cites it directly · 2 of its ownK063382 HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc. · 2006
  8. Descendant · 2 generations on · 1 of its ownK222775 Aarhus Applicator SetVarian Medical Systems, Inc. · 2023
  9. Descendant · cites it directly · 1 of its ownK063381 CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12012: 12015: 22020: 12023: 12025: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 9 · See all
  • K1508393D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring…Varian Medical Systems, Inc. · 2015 · cites it directly2descendants
  • K122840CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc. · 2012 · cites it directly2descendants
  • K063382HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc. · 2006 · cites it directly2descendants
  • K222775Aarhus Applicator SetVarian Medical Systems, Inc. · 2023 · 2 generations on1descendant
  • K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K864210Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp.1986—
−2K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp.1996—
−1K011657HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc.20012
0 (this device)K030110CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc.2003—
+1K1508393D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set…Varian Medical Systems, Inc.2015—
+1K122840CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc.2012—
+1K063382HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc.2006—
+2K222775Aarhus Applicator SetVarian Medical Systems, Inc.2023—
+1K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
201210
201520
202010
202310
202510
FIG. 1 — Lineage of K030110, 1986–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JAQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JAQ device

  1. #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K011657HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc.20012

Also cleared against K011657: 3 other devices →

What descends from it? (9)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1508393D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring…Varian Medical Systems, Inc.20152
K122840CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc.20122
K063382HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc.20062
K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.20061
K142597Vienna SystemMick Radio-Nuclear Instruments, Inc.20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 12, 2008Not classifiedZ-2081-2008Device DesignMedical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K150839 (Varian Medical Systems, Inc., 2015) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K011657.

How does its category compare?

All JAQ devices

JAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAQ

6in 2025

2007: 112008: 102009: 102010: 22011: 22012: 72013: 62014: 72015: 112016: 62017: 72018: 72019: 22020: 42022: 12023: 22024: 102025: 62026 (partial year): 2
2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007: 48 days median2008: 34 days median2009: 27 days median2012: 89 days median2013: 100 days median2014: 116 days median2015: 183 days median2016: 154 days median2017: 229 days median2018: 252 days median2020: 62 days median2024: 126 days median2025: 91 days median
2007high 252 (2018) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAQ

1in 2019

2008: 52009: 12010: 22011: 132012: 52013: 12019: 12026 (partial year): 3
2007high 13 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAQ

3in 2025

2007: 132008: 322009: 352010: 362011: 422012: 342013: 432014: 182015: 72016: 32017: 52018: 22019: 82020: 82021: 52022: 52023: 32024: 12025: 3
2007high 43 (2013) · low 1 (2024)2025

MAUDE reports naming product code JAQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071148013
20081034532
20091027135
20102—236
20112—1342
2012789534
20136100143
20147116018
20151118307
2016615403
2017722905
2018725202
20192—18
202046208
20210—05
20221—05
20232—03
20241012601
202569103
20262—3—

What is it indicated for?

The Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor is indicated for High Dose Rate irradiation of the uterus and cervix.

Indications for use as stated in the FDA summary.

Also cleared against K011657

3 other devices cite the same predicate.

  • K123912Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator SetSpencer Fillmore · 2013
  • K082530Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008
  • K063382HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc. · 2006

More from Mick Radio-Nuclear Instruments, Inc.

43 FDA decisions under this applicant name. See the company

  • K230155Mick Valencia Applicator SetMick Radio-Nuclear Instruments, Inc. · 2023
  • K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT…Mick Radio-Nuclear Instruments, Inc. · 2020
  • K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. · 2016
  • K142597Vienna SystemMick Radio-Nuclear Instruments, Inc. · 2015
  • K122840CT HDR Tandem/Ring Applicator with Rectal Retractor Model 0407Mick Radio-Nuclear Instruments, Inc. · 2012

Recent decisions in JAQ

The JAQ category page

  • K262383LumenCare AzureNucletron B.V. · 2026
  • K252717MAASTRO Rectal Applicator SetVarian Medical Systems · 2026
  • K251037Rectal ApplicatorNucletron B.V. · 2025
  • K252884Guided Aarhus Applicator SetVarian Medical Systems · 2025
  • K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025

https://510kreport.com/device/K030110 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030110: CT HDR Tandem/Ring Applicator with Rectal Retractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030110

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026